我國健康食品製造良好作業規範與歐美管理制度之探討   全文下載

Comparison between the management system of Good Manufacturing Practice for health food in Taiwan and European and the USA

我國之健康食品係指具有保健功效，並標示或廣告其具該功效之食品，且其製造過程應符合良好作業規範（Good Manufacturing Practice, GMP）。目前世界各國對健康食品類似產品具有不同之名稱、定義及管理規範，且其對產品製造過程之管理內容及強度亦不盡相同，本文除介紹我國現行健康食品GMP管理內容外，亦同時探討歐盟及美國於保健食品GMP制度架構及內容，及比較其與我國健康食品GMP規範之差異處。經研究比較，相較於我國對健康食品GMP內容，發現歐美等先進國家較為強調業者應自主管理其產品之製造品質，並將其意涵落實於相關管理規範中，以促使製造業者可發揮自主管理之精神，並可有效提升該類產品之製造品質。透過對歐美保健食品GMP制度進行探討，將有助於持續精進我國健康食品GMP之管理內容及接軌於國際社會，並可提升我國健康食品製造業者之國際競爭力。

Health food in Taiwan refers to the food with health care effects and labeled or advertised with such effects, and their manufacturing process shall comply with Good Manufacturing Practice (GMP). Currently, health food or related food products have different denomination, definition and management regulations in different countries around the world, and the content and strength of the management on manufacturing process for those food products are also different. This article not only introduces the current GMP of health food in Taiwan, but also investigates the GMP of food/dietary supplements in European and the USA, and compares the differences between the structure and content of the GMP regulation or system. In contrast, the GMP systems in advanced countries such as European and the USA emphasize much more on the independent management of the food/dietary supplements manufacturing quality, and integrate those into relevant management regulations to illuminate the spirit of self-management, which effectively improve the manufacturing quality. Through the investigation for the GMP systems of food/dietary supplements in European and the USA, current GMP of health food in Taiwan will continue to improve its management content in order to align with the international community, and enhance the international competitiveness for the health food manufacturers in Taiwan.